My HPRA: Register

Summary of Field Safety Notices - October 2017

Notice type: 3rd Party Publications

Date: 02/11/2017

Further Information:
Abbott
Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra
Advice regarding the use of the device. HPRA Ref: V33046

Alba Bioscience Limited
ALBAcyte Reagent Red Cells for Antibody Identification (Papainised)
Advice regarding a device removal. HPRA Ref: V33513

Biomerieux
VITEK 2 GP ID
Advice regarding the use of the device. HPRA Ref: V33570

Carefusion/ BD
Alaris™ / Asena ™ GS, GH, CC, TIVA, PK, Syringe Pump- Pre 2008
Advice regarding the use of the device. HPRA Ref: V33494

Cepheid
Xpert EV® assay
Advice regarding a device removal. HPRA Ref: V33503

Cook Medical Europe
Wills-Oglesby Percutaneous Gastrostomy Set
Advice regarding a device removal. HPRA Ref: V33658

CR Bard
BARD MAX-CORE Disposable Core Biopsy Instrument
Advice regarding a device removal. HPRA Ref: V33583

Datex-Ohmeda, Inc.
Carestation 620, Carestation 650, Carestation 650c
Advice regarding a device modification. HPRA Ref: V33645

DePuy Synthes
Impactor for PFNA Blade
Advice regarding a device removal. HPRA Ref: V30236

DePuy Synthes
Acetabular Cup Introducer (32mm)
Advice regarding a device removal. HPRA Ref: V33657

Draeger Medical Systems Inc.
Dual Hemo MCable pod used with the Infinity Acute Care System (IACS)
Advice regarding a device modification. HPRA Ref: V33471

Endologix
Nellix EndoVascular Aneurysm Sealing System
Advice regarding the use of the device. HPRA Ref: V33504

Fisher & Paykel Healthcare
RT021 Catheter Mount
Advice regarding a device removal. HPRA Ref: V33531

Hill-Rom
Liko® Multirall™ 200 and S65
Advice regarding the use of the device. HPRA Ref: V33533

HMT Medizintechnik
PLEGIOX Cardioplegia Heat Exchanger
Advice regarding the use of the device. HPRA Ref: V33398

HTL-STREFA SA
Microdot Droplet Pen Needle 4mm x 32G28G, type 810
Advice regarding a device modification. HPRA Ref: V33449

Intelerad
Intelepacs Versions 3.5.1 and up
Advice regarding a software upgrade. HPRA Ref: V33411

LivaNova
Perfusion Tubing System Packs
Advice regarding a device removal. HPRA Ref: V33542

Maquet
Atrium Thoracic Catheters
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30674

Maquet Cardiopulmonary GmbH
Heater-Cooler Units HCU 20 and HCU 30
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33660

Maxter
MAXTER ENTRAL* ENFIT® NASOGASTRIC (NG) FEEDING TUBES
Advice regarding a device removal. HPRA Ref: V30605

Medacta
GMK Primary PS and GMK Sphere Tibial Insert
Advice regarding the use of the device. HPRA Ref: V33481

Medacta
GMK Hinge System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33648

Mediplus Limited
Silicone 2 way Foley Catheter Kit, 16Fr., Open Tip, Standard
Advice regarding a device removal. HPRA Ref: V33562

Medline Industries
Soft suction liner 3000cc/ml (with tube / Med-Gel) 3L MED-SOFT Liner
Advice regarding a device removal. HPRA Ref: V33667

Medtronic
FlexCath Advance™ Steerable Sheath
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33548

Medtronic
Neuray® Neurosurgical Patties and Strips and Merocel® Neurosurgical Patties and Packing
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33343

Oculentis
Lentis foldable Intraocular lenses
Advice regarding a device removal. HPRA Ref: V33214

ottobock
Voyager Evo - Rigid Frame Wheelchair
Advice regarding a device modification. HPRA Ref: V33544

Pentax
PENTAX Endsopes (multiple types)
Advice regarding a device modification. HPRA Ref: V33601


Philips Healthcare
SureSigns VSi, SureSigns VS2+ monitors
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33253

Philips Healthcare
Philips M1783A/M5526A Sync Cables & 989803195641 ECG Out Cables
Advice regarding a device removal. HPRA Ref: V22727

Philips Medical Systems
Mobile Detector Holder
Advice regarding a device modification. HPRA Ref: V33086

Philips Medical Systems
Brilliance 64/ Ingenuity CT / Ingenuity Core / Ingenuity Core128
Advice regarding a software upgrade. HPRA Ref: V33181

Radiometer
TCM5 FLEX/BASIC used with ECG Monitors
Advice regarding the use of the device. HPRA Ref: V33532

Siemens Healthineers
Artis Zee, Artis Q Systems, with software version VD11C
Advice regarding a software upgrade. HPRA Ref: V33108

Siemens Healthineers
Artis system wireless foot switches delivered after January 1, 2005
Advice regarding a device modification. HPRA Ref: V30956

Smiths Medical
CADD® Medication Cassette Reservoirs (Non Flow-Stop), 50ml and 100ml
Advice regarding a device removal. HPRA Ref: V33553

Stago
Néoplastine® CI Plus 2, Néoplastine® CI Plus 5, STA - Néoplastine® CI 5, STA - Néoplastine® CI Plus 5
Advice regarding the use of the device. HPRA Ref: V33603

Stryker Orthopaedics
MAKO PKA & THA software of RIO system (MAKO Robot)
Advice regarding a software upgrade. HPRA Ref: V33193

Stryker Orthopaedics
rHead® System Radial Head Arthroplasty / Uni Elbow
Advice regarding a device removal. HPRA Ref: V33602

Teleflex Medical
WECK® Auto Endo5® Automatic Hem-o-lok® Clip Appliers
Advice regarding a device removal. HPRA Ref: V33508

Vascutek Ltd.
Anaconda™ ONE-LOK™ AAA Stent Graft System; Anaconda™ Iliac Stent Graft System; Anaconda™ AAA Stent Graft System Aortic Cuff
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33417

Vygon
Premicath Neonatal PICC with Stylet
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33254

Vygon
Octopus extension lines
Advice regarding a device removal. HPRA Ref: V33598

Wilson Instruments (Shanghai) Co. Ltd.
Disposable Cleaning Brush
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32698

Zimmer Biomet
Pulsavac Plus Device. FSN 1
Pulsavac Plus Device. FSN 2
Advice regarding the use of the device. HPRA Ref: V33526

Zimmer Biomet
Hex Driver, 2.5 mm with GemLock® Retention
Advice regarding a device removal. HPRA Ref: V33569

Zimmer Biomet
Specific Hip and Trauma Instruments
Advice regarding a device removal. HPRA Ref: V33461

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